Diabetes Mellitus, Type 2
Conditions
Brief summary
The study will evaluate the feasibility, acceptability, and effectiveness of AYUDA (Assisting Younger Adults with Diabetes), a 12-week culturally text message program for Latinx adults newly diagnosed with type 2 diabetes who are caregivers to a child under 18 years old within Kaiser Permanente Northern California.
Detailed description
After designing the AYUDA program with input from the people it is meant to help, we are conducting a randomized pilot study. This study will test the program with younger Latinx adults who have recently been diagnosed with type 2 diabetes and who are also caregivers for dependent children. AYUDA is a health system specifically designed for this group, focusing on their life stage as young adults and their cultural background. The study will evaluate how well AYUDA helps participants reach important early blood sugar control goals, which can lead to better health over time and reduce complications.
Interventions
BEHAVIORALAYUDA Program
Participants randomized to the intervention arm will be enrolled in the AYUDA program, where they will receive text messages twice a week over 12 weeks containing diabetes education and self-management resources, including links to resources available to all KPNC members.
Sponsors
Kaiser Permanente
American Diabetes Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* KPNC member, age \>18 and age \<45 with * New clinical diagnosis of T2D within the prior 6 months * Caregiver to at least one child \<18 years of age at time of diabetes diagnosis * Identifies at Latino/a/x * Can receive text messages * Proficient (written and spoken) in English or Spanish
Exclusion criteria
* Pregnant women * Type 1 Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences between study arms in HbA1c change 6-months following enrollment | 6-months following enrollment | Change in HbA1c will be assessed using HbA1c values obtained through routine care, with the most recent HbA1c preceding study enrollment and the HbA1c value closest to 6-months following enrollment used to assess HbA1c change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant-reported measures: Diabetes distress | Study enrollment and 6-months following enrollment | Assessed at study enrollment and 6-months following enrollment |
| Participant-reported measures: Motivation and locus of control | Study enrollment and 6-months following enrollment | Assessed at study enrollment and 6-months following enrollment |
| Participant-reported measures: Care Experience | Study enrollment and 6-months following enrollment | Assessed at study enrollment and 6-months following enrollment |
| Participant-reported measures: Children's Behaviors | Study enrollment and 6-months following enrollment | Assessed at study enrollment and 6-months following enrollment |
| Completion of recommended HbA1c monitoring | 6-months following enrollment | Completing HbA1c labs |
| T2D-related medication initiation | 6-months following enrollment | Initiation of T2D-related medication |
| T2D-related medication adherence | 6-months following enrollment | Adherence to T2D-related medication |
| Use of remote glucose monitoring to measure glucose levels | 6-months following enrollment | Use of a remote glucose monitoring to measure glucose levels |
| Healthcare contact | 6-months following enrollment | Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators. |
Countries
United States
Outcome results
None listed